PlainRecalls
FDA Devices Moderate Class II Terminated

Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument

Reported: April 20, 2022 Initiated: February 10, 2022 #Z-0912-2022

Product Description

Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument

Reason for Recall

Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

Details

Recalling Firm
Nextremity Solutions
Units Affected
285 units
Distribution
Distribution US Nationwide, Japan, and the Netherlands
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument. Recalled by Nextremity Solutions. Units affected: 285 units.
Why was this product recalled?
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Which agency issued this recall?
This recall was issued by the FDA Devices on April 20, 2022. Severity: Moderate. Recall number: Z-0912-2022.